MAUDE Adverse Event Report: MICROVENTION, INC WEB; NEUROVASCULAR EMBOLIZATION COIL

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ischemia (1942); Paresis (1998)

Event Type  Injury  

Event Description

As reported through the journal article titled - comparison of the contour neurovascular system and woven endobridge device for treatment of wide-necked cerebral aneurysms at a bifurcation or sidewall.This was a prospective review of clinical and radiological data that was collected for all patients treated with the contour or web at a center from may 2018 until june 2022.Both unruptured and ruptured aneurysms, positioned at either a bifurcation or sidewall, were deemed suitable for treatment with either device.Two asymptomatic thromboembolic events were noted on postinterventional mri.In 1 case, the patient presented with acute hemiparesis after waking up postoperatively, despite correct deployment and satisfactory control angiography.Repeat angiography showed protrusion of the web and unrecanalizable occlusion of the superior temporal branch leading to 1 major ischemic event.This report will capture the 1 major ischemic event.

Manufacturer Narrative

Article referenced - hecker, constantin, et al.Comparison of the contour neurovascular system and woven endobridge device for treatment of wide-necked cerebral aneurysms at a bifurcation or sidewall.Journal of neurosurgery 1.Aop (2023) 1-10.The device was implanted in the patient and not returned to the manufacturer for evaluation.Procedural and medical information was provided.The investigation is currently ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.

Manufacturer Narrative

A detailed procedure note medical review has been performed for complaint (b)(4).Journal article reviewed a comparison of the contour neurovascular system and woven endo bridge device for the treatment of wide-neck cerebral aneurysms at a bifurcation or sidewall.Prospective study data reviewed and compared 40 aneurysms in 34 patients treated with the contour and 30 aneurysms in 30 patients treated with the web.Data review of the results indicated that the contour device results were promising, although longer follow-up is necessary to draw more solid conclusions on the utility and risk profile of this new device compared with the already widely used web device.Adequate occlusion at last follow-up was the same for both devices, whereas the probability of complete occlusion at last follow-up was significantly higher for the contour, and the web showed a significantly higher retreatment rate.Article date indicates that prospective clinical and radiological data were collected for all patients treated with the contour or web at our center from (b)(6) 2018 until (b)(6) 2022.Both unruptured and ruptured aneurysms, positioned at either a bifurcation or sidewall, were deemed suitable for treatment with either device.Web on-label ifu data states that the safety and effectiveness of the web embolization device has not been established for ruptured intracranial aneurysms.Article data review further indicates that the contour devices include the lack of data regarding effective use in ruptured aneurysms.The study data also indicates the limitations are the modest number of patients, with mid- to long-term follow-up of only 10¿20 cases in both cohorts, while the median follow-up was significantly shorter in the contour cohort (p = 0.002).No patient injury or harm was reported in the article data for the web device.A visual inspection of the device captured in this file could not be performed as a physical device was not returned for evaluation, nor were any images of the device provided in place of a device return.Procedure and medical imaging was not provided for this investigation.Without the return and physical evaluation of the device, the investigation cannot definitively determine if a condition existed that would have caused or contributed to the reported event.Without imaging, the investigation cannot verify the event occurred as described, nor could the investigation definitively determine the cause of the reported event.Based on a review of the device¿s risk documentation, the reported event did not indicate there were any potential or new manufacturing, design, quality, or other systemic issues, or non-conformances.The complaint code is monitored through the trending process; corrective action is determined, as needed, through this process.Investigations of historic complaint files with similar complaint category coding are recorded in the complaint handling system; without the ability to perform and analysis of the device, this investigation cannot identify with certainty any potential root causes.A search for non-conformances associated with this part/lot number combination could not be performed as this information was not available at the time this investigation was performed.A search of the complaint handling system could not be performed to determine if other similar complaints exist for this batch number, because the batch number was not provided for the product on this complaint file.Ifu review (additional information can be found in the ifu): potential complications potential complications include but are not limited to the following: hematoma at the site of entry, aneurysm rupture, emboli, vessel perforation, parent artery occlusion, hemorrhage, ischemia, vasospasm, clot formation, device migration or misplacement, premature or difficult device detachment, non-detachment, incomplete aneurysm filling, revascularization, post-embolization syndrome, and neurological deficits including stroke and death.Users and/or patients should report any serious incidents to the manufacturer and the competent authority of the member state or local health authority in which the user and/or patient is established.

Event Description

No new additional information was received.See h10.

• Brand Name: WEB
• Type of Device: NEUROVASCULAR EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 16452954
• MDR Text Key: 310347602
• Report Number: 2032493-2023-00585
• Device Sequence Number: 1
• Product Code: OPR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other